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Model Number 411660 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Intended use: bact/alert® virtuo® microbial detection system is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids and from blood platelet samples.Issue description: a customer in sweden notified biomérieux of obtaining no result in association with their virtuo® a unit (ref.(b)(4), serial (b)(6)).It was reported that customer can´t find bottles in their virtuo, last action from both myla and audit trail is bottle reloaded 6/6.When searching in virtuo there is no result for the bottle ids missing.Customer is concerned about how they can find info of the bottle, if it stayed in the cell 5 days so it is considered negative, or if it was removed before that.In this context, the result was delayed as it was more than 5 days since the bottles were loaded.No patient health impact has been reported due to delayed results.Biomérieux global customer service requested additional information to understand why these bottles cannot be found in the virtuo application and why the information was not sent to myla.An investigation has been initiated.At the time of the global assessment, there is no indication or report from the customer that the no result led to any adverse event related to any patient's state of health.An investigation has been initiated.
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Manufacturer Narrative
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Context: complaint investigation inv-15801 was initiated for a complaint relating to several lost bottles on two bact/alert® virtuo® a units (part number 411660, serial number (b)(6) and (b)(6) with software version r03.01.01.1274 ; no result was present for these bottles.There are two clinical hospital customer site locations in sweden where these two a units are located so two complaint cases were created (b)(4).The two a units are connected together in a primary/secondary configuration using a myla® server, and they are located in different cities.The customer stated that ten (b)(4) bottles were found in the hospital¿s lis (laboratory information system) that should have negative results by now as they are past 5 days old.There was no harm to any patient reported to the laboratory, but they could not request the details or further information from the physician without authorization.Investigation: capa and trend analysis.There are no containment or correction actions required by biomérieux.The issue is isolated to this one customer system, no adverse trend for this issue was found in the complaint or manufacturing data.No adverse trend was identified in the complaint database or manufacturing database related to this investigation.The bottles were found to have tested on the instrument and had final negative results.Investigation root cause analysis.The investigation involved reviewing instrument log files for the ten bottle ids provided by the customer as involved in this issue.The root cause of the issue is the customer ignoring persistent scheduled backup and purge failure alarms.When the scheduled backup has a failure, data is not purged from the system.Hence, the purge failure alarm.When data is not purged from the system, the size of the database grows.This led to the lack of free disc space on the virtuo pc e: drive, where the database lives, that caused the code 500 internal server errors.The recommended corrective action is to replace or reimage and restore the virtuo pc on the primary a-unit to factory settings.This recommendation was provided because the backup and purge failure alarms have been ongoing since 2021.A similar case of a purge failure from the same customer was reported on (b)(6) 2021.The corrective action of replacing the primary a-unit virtuo pc was implemented at the customer site.The issue of lost bottles has not recurred since the pc replacement happened.The corrective action was completed, as the pc has been replaced by the field service engineer.The recommended preventive action is to address alarms as they appear and report persistent alarms to biomerieux immediately.Per the virtuo user manual the resolution for the backup and purge failure alarms state, ¿if the problem persists, contact your local biomerieux representative for assistance¿.Conclusion: no specific harm to a patient was reported.The bottles were found to have tested on the instrument and had final negative results.No product malfunction was identified.The root cause is related to the user not responding to reoccurring instrument alarms for backup and purge failures.Once the database size reached its limit, the system performance was impacted.
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Search Alerts/Recalls
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